Humira, a popular medication used to treat rheumatoid arthritis, psoriasis, Crohn’s Disease, and other autoimmune diseases, has been linked to serious, life-threatening side effects, including nerve damage, cancer, and opportunistic fungal infections.
Humira is a pharmaceutical medication used to the treatment of autoimmune diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease. It is owned by Abbott Laboratories, and was developed as the first “biologic” drug, which means that is made from natural substances in the body. It is the first drug in its class made up of actual human cells. Since it was approved in 2003 for the treatment of rheumatoid arthritis, it has been a “blockbuster” medication, and is now approved for five autoimmune diseases. Worldwide sales were approximately $6.5 billion in 2010, and it is expected to become the world’s most lucrative pharmaceutical by 2016.
Humira Lawyer files Humira Lawsuit
Several lawsuits have been filed regarding adverse effects, including:
Each Humira lawsuit alleges that Abbott Laboratories knew of the risks, but failed to adequately warn consumers. In addition, when the FDA asked the drug company to update the safety information, it did not do so for months. In the case of fungal infections, Abbott Laboratories waited for more than a year to update its safety information.
Humira and Cancer
Humira belongs to a class of medications called “tumor necrosis factor-blockers,” which blocks the body’s cancer-destroying cells, and also suppresses the body’s immune system.
According to the FDA, Abbot Laboratories did not clearly warn consumers risk of side effects of using Humira, including the risk of developing lymphoma and other types of cancer. The company based its safety information on just four trials that tested the drug on only 2,070 patients. During these trials, a number of people developed lymphoma and other serious side effects, at a significantly increased rate compared to people who received a placebo.
Studies have found that the risk of developing lymphoma may be three times greater while taking Humira.
Despite the evidence that Humira could cause serious side effects, Abbott did not conduct more studies. They also did not make the safety warnings clear or obvious on the safety label, prompting action from the FDA. At the end of 2003, the first year Humira was approved, the FDA had received 365 reports of serious adverse events, including cancer. Because these are self-reported, they vastly underestimate the actual number of events.
A Mayo Clinic study from 2006 linked Humira to cancers of the skin, gastrointestinal system, breast, and lung. However, Abbott did not clearly warn people of the risk of cancer until the FDA required changes to the safety labeling in 2009.
Humira and Nerve Damage
Humira may cause permanent nerve damage, called “peripheral neuropathy.” People with this injury often suffer constant, debilitating pain, tingling, or numbness. They may also have muscle problems, organ damage, bladder problems, and sexual problems.
Doctors at Angers University in France found a link between Humira and nerve damage, and published the results in April 2006. Abbott Laboratories should have been aware of the results of the study of its product, but it failed to warn consumers prior to the drug’s launch in 2007 for the treatment of Crohn’s disease.
Humira and Infections
Some people who have received injections of Humira have subsequently developed life-threatening fungal infections. Despite the fact that Abbott Laboratories knew from clinical trials that their drug suppressed the body’s immune system, making it vulnerable to infections, they failed to include this in the safety information until the FDA required it in 2009.
As of today, Abbott has complied with FDA mandates and the safety information includes warnings of Invasive Fungal Infections in the Medication Guide. However, prior to 2009, the company did not warn consumers of this risk.